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Title: Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke
Authors: Sacco, Ralph L ×
Diener, Hans-Christoph
Yusuf, Salim
Cotton, Daniel
Ounpuu, Stephanie
Lawton, William A
Palesch, Yuko
Martin, Reneé H
Albers, Gregory W
Bath, Philip
Bornstein, Natan
Chan, Bernard P L
Chen, Sien-Tsong
Cunha, Luis
Dahlöf, Björn
De Keyser, Jacques
Donnan, Geoffrey A
Estol, Conrado
Gorelick, Philip
Gu, Vivian
Hermansson, Karin
Hilbrich, Lutz
Kaste, Markku
Lu, Chuanzhen
Machnig, Thomas
Pais, Prem
Roberts, Robin
Skvortsova, Veronika
Teal, Philip
Toni, Danilo
Vandermaelen, Cam
Voigt, Thor
Weber, Michael
Yoon, Byung-Woo #
Contributors: Thijs, Vincent
Issue Date: Sep-2008
Series Title: New England Journal of Medicine vol:359 issue:12 pages:1238-1251
Abstract: BACKGROUND: Recurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens--aspirin plus extended-release dipyridamole (ASA-ERDP) versus clopidogrel. METHODS: In this double-blind, 2-by-2 factorial trial, we randomly assigned patients to receive 25 mg of aspirin plus 200 mg of extended-release dipyridamole twice daily or to receive 75 mg of clopidogrel daily. The primary outcome was first recurrence of stroke. The secondary outcome was a composite of stroke, myocardial infarction, or death from vascular causes. Sequential statistical testing of noninferiority (margin of 1.075), followed by superiority testing, was planned. RESULTS: A total of 20,332 patients were followed for a mean of 2.5 years. Recurrent stroke occurred in 916 patients (9.0%) receiving ASA-ERDP and in 898 patients (8.8%) receiving clopidogrel (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11). The secondary outcome occurred in 1333 patients (13.1%) in each group (hazard ratio for ASA-ERDP, 0.99; 95% CI, 0.92 to 1.07). There were more major hemorrhagic events among ASA-ERDP recipients (419 [4.1%]) than among clopidogrel recipients (365 [3.6%]) (hazard ratio, 1.15; 95% CI, 1.00 to 1.32), including intracranial hemorrhage (hazard ratio, 1.42; 95% CI, 1.11 to 1.83). The net risk of recurrent stroke or major hemorrhagic event was similar in the two groups (1194 ASA-ERDP recipients [11.7%], vs. 1156 clopidogrel recipients [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11). CONCLUSIONS: The trial did not meet the predefined criteria for noninferiority but showed similar rates of recurrent stroke with ASA-ERDP and with clopidogrel. There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke. (ClinicalTrials.gov number, NCT00153062.)
URI: 
ISSN: 0028-4793
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Research Group Experimental Neurology
Laboratory for Neurobiology (Vesalius Research Center)
× corresponding author
# (joint) last author

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